FDA.report

INKA

Primary DI
09348811099129
Brand
INKA
Company
The Trustee for KAISER FAMILY TRUST
Model
33691.40
Catalog number
33691.40
Device description
EICKEN Antrum Cannula Luer-lock connector short curve ø 4.0mm 15cm
Published
2025-11-28
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
false
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
KAMCannula, Sinus

Product Code Classifications

CodeDeviceSpecialtyClass
KAMCannula, SinusGeneral, Plastic Surgery1

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
09348811099129PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifierGTIN-14 normalizedEAN-13
09348811099129093488110991299348811099129

GMDN Terms

TermDefinition
ENT suction dissectorA hand-held surgical instrument, formed in the shape of a tube, used to provide dissection while controlling intraoperative bleeding, and for the removal of debris/fluids, during ear/nose/throat (ENT) surgery. The device is connected to the tubing of a suction system at the proximal end and there is an opening at the working end through which the suction is applied to the site. The distal end is typically shaped as a rounded, flat blade, allowing the two functions to be applied simultaneously. It will have fingertip suction control and eliminates the need for a separate suction tip. It is made of metal and comes in various shapes and sizes. This is a reusable device.

Sterilization Methods

Method
Moist Heat or Steam Sterilization

Regulatory Flags

DUNS number
742109993
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
true

Other Devices From This Company

Primary DIBrandModelCatalogPublished
09348811023018INKA15341.152026-03-16
09348811023667INKA15423.112026-03-16
09348811103338INKA30420.142026-03-16
09348811111906INKA31252.032026-03-16
09348811112002INKA31255.082026-03-16
09348811150134INKA31270.16 RD2026-03-16
09348811151254INKA18261.142026-03-16
09348811103321INKA30420.082026-03-09
09348811150288INKA31241.16 RD2026-03-09
09348811150356INKA31252.12 RD2026-03-09
09348811000873INKA10236.3010236.302026-02-13
09348811000897INKA10237.1510237.152026-02-13
09348811000903INKA10237.1710237.172026-02-13
09348811000927INKA10237.1410237.142026-02-13
09348811000934INKA10237.2010237.202026-02-13
09348811000941INKA10237.2310237.232026-02-13
09348811000958INKA10237.2810237.282026-02-13
09348811000965INKA10237.3010237.302026-02-13
09348811000972INKA10237.3310237.332026-02-13
09348811000989INKA10237.3610237.362026-02-13

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
09348811099082INKAThe Trustee for KAISER FAMILY TRUSTKAM2025-11-28
09348811099099INKAThe Trustee for KAISER FAMILY TRUSTKAM2025-11-28
09348811099112INKAThe Trustee for KAISER FAMILY TRUSTKAM2025-11-28
04250676740618Laryngeal cannulaSpiggle & Theis Medizintechnik GmbHKAM2025-09-12
00757770420797Bausch + LombBausch & Lomb IncorporatedKAM2025-08-15
00757770683505Bausch + LombBausch & Lomb IncorporatedKAM2025-08-05
00194613023133MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-08-01
00194613102364MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-08-01
00194613102388MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-08-01
00194613107444MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-08-01
00194613107451MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-08-01
00194613108571MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-08-01
B3901912038T1Reprocessed 4mm EndoScrub 2 Sheath, 0 deg, w/TubingSURETEK MEDICALKAM2025-05-01
B390197230CVA1Reprocessed 4mm EndoScrub Sheath, 70 deg, K StorzSURETEK MEDICALKAM2025-04-25
00194613065379MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-03-21
00194613102371MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-03-21
00194613102746MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-03-21
00194613108502MSI Precision Specialty InstrumentsMed Saver, Inc.KAM2025-03-21
20080196392275MEDLINEMEDLINE INDUSTRIES, INC.KAM2025-02-14
20888277371771MEDLINEMEDLINE INDUSTRIES, INC.KAM2025-02-14
04250676742360Suction tubeSpiggle & Theis Medizintechnik GmbHKAM2024-12-27
08904461006873OSSEOUS Suction Tube for Sinus-DisposableEON MEDITECH PRIVATE LIMITEDKAM2024-07-03
08904461006880OSSEOUS Suction Tube for Sinus-DisposableEON MEDITECH PRIVATE LIMITEDKAM2024-07-03
04049197306263RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAM2024-06-28
04049197306270RZ Medizintechnik GmbHRZ-Medizintechnik GmbHKAM2024-06-28
08906039316452OSSEOUS Suction tubes for Nose ReusableEON MEDITECH PRIVATE LIMITEDKAM2024-06-26
08906039316445OSSEOUS Suction tubes for Nose Reusable EON MEDITECH PRIVATE LIMITEDKAM2024-06-26
08904428747443OSSEOUS Suction tubes for SinusEON MEDITECH PRIVATE LIMITEDKAM2024-06-25
08906039316889OSSEOUS Suction Tubes for Nose DisposableEON MEDITECH PRIVATE LIMITEDKAM2024-06-25
08906039316582OSSEOUS Suction tubes for Nose ReusableEON MEDITECH PRIVATE LIMITEDKAM2024-06-25